Flourish Vaginal Care System for Neovaginal Microbiome Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sexual Health and Wellness Institute

Disqualifiers: Immunosuppressed, Allergies, Vaginal infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial examines if a store-bought vaginal health kit, called the Flourish Vaginal Care System, can help transgender women who have had gender-confirming surgery develop a healthy vaginal environment. The kit aims to promote good bacteria, similar to what is found in healthy cisgender women. The goal is to improve overall vaginal health and satisfaction for these women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Flourish Vaginal Care system treatment for neovaginal microbiome health?

Research suggests that promoting Lactobacillus colonization with probiotics can help maintain a healthy vaginal microbiome, which is important for women's reproductive health. Although specific data on the Flourish Vaginal Care system is not available, similar treatments using probiotics have shown potential benefits in managing the vaginal microbiome. ^{1 2 3 4 5}

Is the Flourish Vaginal Care System safe for human use?

A study on a similar intravaginal system with DL-lactic acid showed no irritation or adverse events in a small group of healthy women, suggesting it may be safe for human use. ^{1 6 7 8 9}

How is the Flourish Vaginal Care System treatment different from other treatments for neovaginal microbiome health?

The Flourish Vaginal Care System is unique because it likely focuses on using probiotics, specifically lactobacilli, to maintain a healthy vaginal microbiome, which is different from traditional antibiotic treatments. This approach leverages the natural role of lactobacilli in acidifying the vaginal environment and inhibiting harmful microorganisms, offering a potentially safer and more natural alternative. ^{1 4 10 11 12}

Research Team

Christine McGinn, DO

Principal Investigator

Papillon Center

Eligibility Criteria

This trial is for healthy cisgender women aged 18-52 and transgender women over age 18 who are planning to have gender-confirmation surgery. Participants should not be allergic to aloe vera or components of the Flourish Vaginal Care system, nor have certain infections or immune suppression.

Inclusion Criteria

I am a healthy woman aged 18-52.

I am a transgender woman over 18 planning for gender-confirmation surgery.

Exclusion Criteria

My immune system is weakened.

I have a vaginal infection that is not yeast or BV.

I cannot tolerate Restore gel after my surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Flourish Vaginal Care System or standard care for 6 months to establish a neovaginal microbiome

6 months

Collections at time 0, 6 weeks, and 6 months

Follow-up

Participants are monitored for changes in vaginal pH and microbiome composition after treatment

4 weeks

Treatment Details

Interventions

• Flourish Vaginal Care system

Trial Overview The study is testing the Flourish Vaginal Care System's ability to establish a healthy microbiome in neovaginas of transgender women post-surgery, using commercially-available wellness products.

Participant Groups

Group I: Group 3: Cisgender women Experimental Treatment 1 Intervention

This group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study.

Group II: Group 1: Transgender women using Flourish Experimental Treatment 1 Intervention

After gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use "Balance" external wash beginning day 6 after surgery; "Restore®" vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with "BiopHresh" homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months.

Group III: Group 2: Transgender women not using Flourish Active Control 1 Intervention

After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months.

Who Is Running the Clinical Trial?

Sexual Health and Wellness Institute

Lead Sponsor

Trials

9

Recruited

170+

Vaginal Biome Science

Lead Sponsor

Trials

10

Recruited

3,400+

Papillon Center

Collaborator

Trials

1

Recruited

60+

Findings from Research

In a pilot study involving 43 healthy premenopausal women, a 10-strain probiotic formulation significantly reduced vaginal pH, indicating potential benefits for vaginal health, particularly in those with intermediate Nugent scores or elevated pH levels.

The probiotic was well tolerated with high compliance, and while it did not significantly change Nugent scores, it maintained lactobacilli abundance, suggesting a positive impact on vaginal microbiota.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study. Martoni, CJ., Frederiksen, AKS., Damholt, A., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotic treatment with specific lactobacilli does not improve an unfavorable vaginal microbiota prior to fertility treatment-A randomized, double-blinded, placebo-controlled trial. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

The effect of probiotic supplementation during pregnancy on the interaction network of vaginal microbiome. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cervicovaginal Microbiota and Reproductive Health: The Virtue of Simplicity. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Complexities of the uniquely human vagina. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

The vaginal microbiome in health and disease. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Twice-daily application of HIV microbicides alter the vaginal microbiota. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Characterization of the Ovine Vaginal Microbiome and Inflammation Patterns as an Improved Testing Model of Human Vaginal Irritation. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Optimal sampling and analysis methods for clinical diagnostics of vaginal microbiome. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Rationale and Safety Assessment of a Novel Intravaginal Drug-Delivery System with Sustained DL-Lactic Acid Release, Intended for Long-Term Protection of the Vaginal Microbiome. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Use of probiotic lactobacilli in the treatment of vaginal infections: In vitro and in vivo investigations. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Integrating compositional and functional content to describe vaginal microbiomes in health and disease. [2023]